The four Phase 2 winners in the NIH’s competition each will receive $1 million, technical assistance and other resources to accelerate the development for neuromodulation therapies — those aimed at stimulating the nervous system to improve function and treat a range of conditions. At UofL, researchers are using these therapies to help patients with paralysis restore functions they may otherwise never have again.

“This technology holds enormous potential for people living with paralysis resulting from spinal cord injury,” said Susan Harkema, a UofL professor, researcher and lead on the Neuromod Prize project. “Our research so far, and the progress we will make supported by this new funding, could dramatically improve all aspects of their daily lives, from movement to cardiovascular function.”

The project team includes UofL researchers Harkema and Charles Hubscher, working in collaboration with Johns Hopkins University Applied Physics Laboratory (APL), Medtronic and long-time clinical translational research partner, the Kessler Foundation. Together, they will develop a novel communication and analysis system, called StimXS, that integrates sensor information to both stabilize blood pressure and improve respiratory and bladder function.

This builds on past work by UofL researchers, who have used neuromodulation to target and improve a range of health effects resulting from spinal cord injury, including cardiac, respiratory and bladder function and even — something previously thought to be impossible. To target these functions, the researchers use an implantable stimulation device that can send electrical signals to select areas of the spinal cord.

“With this new Phase 2 Neuromod funding, we can take a major step toward advancing this technology for broad use in patients,” said Hubscher, professor and co-director of the KSCIRC. “We’ve seen great results in the lab, but the true impact of this technology will be when it’s in a clinical setting and helping the people who need it most.”

This work has also been supported by several public and private sponsors, such as the Christopher and Dana Reeve Foundation, the Craig H. Neilsen Foundation, the Helmsley Charitable Trust and . As part of the Neuromod Prize, Phase 2 winners will be exclusively invited to participate in Phase 3, which will have a total potential prize pool of $5 million. ��

“This is truly game-changing research with the power to improve lives,” said Jon Klein, UofL’s interim executive vice president for research and innovation. “I applaud the research team for their success in driving this important work forward and am excited to see them translate this for broad use in patients.”

The Neuromod Prize is part of the��, which is making critical progress to help accelerate the development of neuromodulation therapies, close fundamental knowledge gaps, and offer tools that enable open science and innovation through the .

“On the 10-year anniversary of the program, it was time to honor and thank the two individuals whose driving vision and support launched what has become the Kosair Charities Center for Pediatric NeuroRecovery by naming these awards in their honor,” said Andrea Behrman, director of the center. “Further, we are proud to present these awards to individuals whose support and contribution have had a significant positive impact on the lives of children with spinal cord injuries and their families.”

The Susan J. Harkema Pediatric NeuroRecovery Research Award honors Harkema’s “enduring generosity in sharing her vision to advance recovery for adults with spinal cord injury to children with SCI, the contributions of her research as the foundation and catalyst for recovery and her unwavering support of the Pediatric NeuroRecovery Program,” Behrman said.

The first recipient of the Susan J. Harkema Pediatric NeuroRecovery Research Award is Yury Gerasimenko, professor in UofL’s . Known as the father of neuromodulation, Gerasimenko extended his spinal stimulation technology and work using neuromodulation to advance motor recovery of postural control, arm and hand function and walking in children with SCI. ��

“His work embodies the characteristics of generosity in sharing his knowledge to advance recovery in children with SCI. We are grateful for his contributions of research and unwavering support of the Pediatric NeuroRecovery Program,” Behrman said.

The second recipient of the Susan J. Harkema Research Award is Goutam Singh, assistant professor at Spalding University and visiting scientist in the Kentucky Spinal Cord Injury Research Center, for his research in pediatric SCI relative to respiratory function, trunk control and neuromodulation.

The A. Keith Inman Pediatric NeuroRecovery Community Service Award recognizes the contributions of Inman, who served as president of Kosair Charities from 2017-2021 and previously as vice president for advancement at UofL. The award honors those who support children and adolescents with spinal cord injury and their families through the gift of their own time and community-based support.

The first recipients of the A. Keith Inman Pediatric NeuroRecovery Community Service Award are Amy Brown and Jennifer Nachreiner of RISE AGAIN, a not-for-profit organization that supports those with spinal cord illness or injury to reach beyond expectations. As parents of children with spinal cord injury, Brown and Nachreiner have first-hand knowledge of the challenges facing parents and families of children with spinal cord injury.

The second recipient is Alyssa Lemons, who established and maintains a Facebook group “” as a resource for parents and caregivers of children and adolescents with spinal cord injury.

On behalf of the awardees, $10,000 ($2,500 for each award) was donated to the Shelley A. Trimble Pediatric NeuroRecovery Fund at the University of Louisville. The Trimble fund provides assistance for children with SCI and their families to fill the gaps in insurance, funding for clinical services at UofL Health – Frazier Rehab Institute and travel and lodging for children and families participating in research at the Center for Pediatric NeuroRecovery.

The Pediatric NeuroRecovery Summit was a two-day educational forum tapping a broad array of expertise on recent scientific research and innovations that may effectively advance the recovery of children with spinal cord injury. More than 35 invited researchers, physicians, therapists, psychologists and SCI community members from across the United States, the United Kingdom and France attended to network and to address progress in recovery in children with spinal cord injury and outreach to educate health care professionals and families concerning the potential for recovery that now exists for these children.

Speakers included Karen Adolph of New York University, Federico Canavese of Universite de Lille, France, Gerasimenko, Singh, Katie Lucas of UofL, and Kyle Brothers and Margaret Calvery of UofL and Norton Children’s, along with parents of children with SCI.

The summit is held every two years in conjunction with the .

On one level, it was a dream come true, but he had to think carefully about it before accepting.

Before he enrolled, he took stock of his goals. Did he have expectations about what he might gain? Was he doing it only for himself? Finally, he was about to get married and it would require relocating to Louisville from his home in New York City for an extended period of time.

Ultimately, he decided his participation could benefit other older SCI patients and those longer post-injury – he was 55 years old and 39 years post injury. The possibility that he could benefit personally was a bonus – but an exciting one.

“My wife said I would be regretting it for the rest of my life if I didn’t do it,” Stifel said. “I admit I was like a kid in a candy shop – I wanted that candy! But I knew I would have to work extra hard.”

From philanthropist to participant

Stifel was 17 years old in 1982 when an auto accident left him paralyzed, unable to walk or use his hands. With support from his family and community, he got on with life, graduating from high school, then college with a degree in finance and pursuing a career on Wall Street.

Hoping to change the trajectory of spinal cord injury research, dubbed the “graveyard of neuroscience,” Stifel and his father started a foundation to raise money and fund research that would give hope for recovery to people with spinal cord injuries. That foundation eventually merged with the American Paralysis Association and later with what now is known as the Christopher and Dana Reeve Foundation, supporting research and advocacy for individuals with spinal cord injury (SCI).

As a board member of the foundation throughout its history, Stifel followed the work of SCI researchers, particularly UofL professor Susan Harkema and . He was impressed with the progress they made using implanted epidural stimulators, from Rob Summers, the first individual implanted with a stimulator for SCI research, to additional participants who experienced voluntary movement, improved cardiovascular function, the ability to stand and improved bowel, bladder and sexual function. Some even took steps because of the implant and specialized therapy developed by the UofL team.

Stifel, now in his 50s, was gratified to see this progress and support the work through the foundation, including “The Big Idea,” a 36-participant study of the benefits of epidural stimulation funded by the Reeve Foundation and led by Harkema. The previous participants were younger and had a shorter length of time since their injury. Although he had been to Louisville to participate in other studies, Stifel believed that because it had been nearly 40 years since his injury, it was unlikely he would be able to participate in the epidural stimulation studies.

Then in 2018, Stifel got a call to participate in The Big Idea. Since his deficits were stable, which gave the researchers a solid starting point to document any gains or changes he might experience, he qualified.

When he arrived in Louisville for the study in 2020, he knew that nothing was guaranteed.

“I understood that you need to go in with zero expectations,” Stifel said. “You can only have expectations if the therapy is proven, but it is still being tested. My goal was to be involved and represent others who are injured as long as me. I wanted to help the research progress.”

Blood pressure regulation and stand training

Stifel’s overall health had remained relatively stable in the years since his injury, without many of the comorbidities people with severe SCI often experience. The one side effect he did have was chronic low blood pressure.

“My blood pressure was typically 80/50, which can be debilitating,” he said. “I became used to it, but it is not a healthy way to live. When I was giving a presentation or having a conversation, I would find myself distracted.”

Once enrolled in the study, Stifel underwent preliminary assessments followed by the surgery to implant the electrode on his spine and the epidural stimulator in his abdomen. Then the researchers did a series of mapping sessions in which the stimulator was tested for each of the areas being studied: voluntary leg movement, trunk control and cardiovascular function.

Stifel was randomized into a cardiovascular arm of the study, which required that he monitor his blood pressure every 15 minutes for six hours a day, keeping his systolic blood pressure between 110 and 120. If it dropped below that, he was to adjust the stimulator to regain that level.

Those sessions brought significant improvement for Stifel.

“I didn’t realize how poorly I felt until it was fixed. I guess you have to feel bad to realize what good feels like,” he said. “When my blood pressure maintains a healthy level, it is like a breath of fresh air. My ability to engage, be proactive and live life is so much easier.”

Now, even when he turns off the stimulator, his blood pressure remains above its previous levels for several hours.

Stifel’s study protocol also included 160 two-hour stand training sessions in the lab at . Every weekday, he would stand upright in a standing frame with trainers supporting his back, chest and each knee. These sessions were to help Stifel gain strength and independence.

“At the end of the sessions, I could consistently stand for 10-to-16 minutes without knee support,” Stifel said. “The epidural stimulator is more intense and effective than anything else I have experienced.”

Moving the needle

Stifel’s time since injury is the longest of any of the participants in the UofL studies so far.

“I am more of an outlier on the low end, but at 56 years old and nearly 40 years post injury, I think I did great,” he said.

Even Harkema was somewhat surprised that Stifel regained voluntary movement as soon as his early sessions led by Claudia Angeli, assistant professor of bioengineering and director of the epidural stimulation program at KSCIRC.

“I admit we had low expectations of Henry being able to move voluntarily after almost four decades of no movement,” said Harkema, professor of neurological surgery and associate director for KSCIRC.��“Even though it supported our theory of the sophistication of the human spinal circuitry, I was stunned when Dr. Angeli was able to find stimulation configurations for him to sit independently and move his toes, ankles, knees and hips in the first sessions. Importantly, this shows that under the right conditions, recovery can happen even decades after injury.”

Now that he has completed his initial part of the study, Stifel is taking part in another study arm in which he will complete another 80 sessions focusing on trunk control and voluntary leg movement.

Once he completes the additional studies, Stifel plans to incorporate training with the stimulator in his daily exercise routine. Although he is not steady enough to stand on his own at home, he will continue that training along with blood pressure regulating, core exercising and any other positive outcomes that might come from this new phase of the study.

“I don’t want to do this study and then shelve it. We accomplished a lot and I want to be able to do more.” Stifel said. “I feel like I won the senior golf tournament, but I still want to beat the kids that have won the Masters. It’s human nature to want more.”

He also is happy to have contributed personally to the overall body of research.

“I think I have helped them move the research needle,” Stifel said. “There have been so many exciting discoveries. Spinal cord injury research has moved from the graveyard of neurological research to interventions that are impacting lives today. This field of research is quickly moving from the traditional fundraising path to one of venture philanthropy and gaining the interest of true capital. Lives are being changed thanks to epidural stimulation, transcutaneous stimulation and the other work being done here and elsewhere.

“This is an amazing research study within the walls of an amazing university. I hope the Louisville community is aware of it and proud of the accomplishments coming from it. It is an amazing time for this field of research.”

Visit Henry Stifel’s blog about his journey with epidural stimulation research at .

To support spinal cord injury research at the University of Louisville, visit .

They are:

• Innovator Winner – Susan Harkema, PhD, professor, Department of Neurological Surgery, UofL School of Medicine; associate scientific director, ; director of research, Frazier Rehab Institute

Harkema was honored for her research and ongoing commitment to the study of human locomotion. She has dedicated her career to the exploration of technology and development of therapies that will allow individuals with spinal cord injury to recover.

• Innovator Finalist – Walter Sobczyk, MD, pediatric cardiologist, University of Louisville, , Norton Children’s Hospital; associate professor, Department of Pediatrics, Division of Pediatric Cardiology, UofL School of Medicine

A finalist in the innovator category, one of Sobczyk’s career highlights was the pioneering work of his pediatric cardiology group to use computer technology to transmit cardiac ultrasounds remotely from small community hospitals throughout the state of Kentucky. This important advancement helped provide high-level care to underserved areas of the state.

• Provider Winner – Erle Austin III, MD, cardiovascular and thoracic surgeon, University of Louisville, ; professor and vice-chairman of the Department of Cardiovascular and Thoracic Surgery, UofL School of Medicine

As winner of the provider category, Austin has spent his career as a physician-educator and surgeon treating adults and children in need of congenital heart repairs. The ability to positively impact a person’s health quickly, along with the challenge of cardiovascular and thoracic surgery made the specialty particularly appealing to him.

• Provider Finalist – Christian Davis Furman, MD, geriatrician, ; professor of geriatric & palliative medicine; interim chief, Division of General Internal Medicine, Palliative Medicine and Medical ����ֱ��, UofL School of Medicine; Margaret Dorward Smock Endowed Chair in Geriatric Medicine; medical director, UofL Trager Institute

Furman was recognized as a finalist in the provider category for her work in the field of geriatrics. She still makes home visits and in her Q&A with Business First says the most rewarding part of her job is bringing together patients and families to discuss goals of care and advance care planning.

Read more about the Healthcare Hero finalists and winners on the .